اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BAXDELA از شرکت MELINTA
New Drug Application (NDA): 208610
Company: MELINTA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BAXDELA | DELAFLOXACIN MEGLUMINE | EQ 450MG BASE | TABLET;ORAL | Prescription |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/19/2017 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/24/2019 | SUPPL-7 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208610Orig1s007, 208611Orig1s006ltr.pdf |
||
| 05/03/2019 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s006,208611s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208610Orig1s006, 208611Orig1s005ltr.pdf |
||
| 10/18/2018 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208610s005,208611s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208610Orig1s005,208611Orig1s004ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/24/2019 | SUPPL-7 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006lbl.pdf | |
| 05/03/2019 | SUPPL-6 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s006,208611s005lbl.pdf | |
| 05/03/2019 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s006,208611s005lbl.pdf | |
| 10/18/2018 | SUPPL-5 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208610s005,208611s004lbl.pdf | |
| 10/18/2018 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208610s005,208611s004lbl.pdf | |
| 06/19/2017 | ORIG-1 | Approval | Label (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf |
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